A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung Cancer

This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer Read More

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
• Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is platinum sensitive.
• PSOC (i.e., epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) with documented radiographic progression or relapse within 6 to 18 months of most recent platinum-based chemotherapy.
• Female participants of childbearing potential must use effective contraception as defined by study protocol and cannot be pregnant or breastfeeding.

NSCLC-specific Inclusion Criteria:

• Histological documentation of incurable, locally advanced, or metastatic non-squamous
• NSCLC that has progressed on prior treatment
• Not more than 2 prior regimens in the metastatic setting, including one prior cytotoxic regimen and one prior non-cytotoxic regimen (prior treatment with adjuvant therapy within 6 months of recurrence is considered a treatment regimen in the metastatic setting).
• For participants with a documented epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement, one additional line of non-cytotoxic prior treatment will be permitted provided the therapy is a targeted agent against the EGFR mutation or ALK rearrangement.
• For participants with lung cancer, centrally confirmed high expression of a sodium-dependent phosphate transporter (NaPi2b) by immunohistochemistry (IHC) is required (i.e., IHC 2+ or 3+).

Exclusion Criteria:

• Anti-tumor therapy of any kind or major surgery within 4 weeks prior to Day 1.
• For ovarian cancer participants only, platinum-based chemotherapy within 6 months prior to Day 1.
• For ovarian cancer participants only, platinum treatment with more than two platinum-based chemotherapy regiments or more than four anti-cancer regimens, overall, for the treatment of ovarian cancer.
• Palliative radiation within 2 weeks prior to Day 1.
• Toxicity (except alopecia and anorexia) from prior therapy or neuropathy of grades > 1.
• Evidence of any significant disease or condition that could affect compliance with the protocol or interpretation of results.
• Known active infection (except fungal nail infections).
• History of liver disease or human immunodeficiency virus (HIV).
• Other malignancy within the last 5 years, except for adequately treated or controlled carcinoma in situ of the cervix or skin cancer or primary endometrial cancer of stage </= 1B.
• Untreated or active central nervous system (CNS) metastases.
• Prior treatment with NaPi2b- targeted therapy.

Bevacizumab-Specific Exclusion Criteria (for Participants in Second Ovarian

Expansion Cohort Only):

• Inadequately controlled hypertension or history of hypertensive crisis or encephalopathy.
• History of heart problems or thrombosis within 6 months prior to study start.
• History of stroke within 6 months prior to study enrollment.
• History of significant vascular disease.
• History of expectoration of blood within 1 month prior to study start or blood clotting problems.
• Core biopsy or other minor surgical procedure within 7 days prior to study start
• Serious and non-healing wound, active ulcer, or untreated bone fracture.